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Completed

NCT Number: NCT00684736

Tryptophan, Serotonin and Kynurenine in Septic Shock

Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Versailles - André Mignot Hospital

Le Chesnay, 78150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above or equal to 18 years
  • Strong presumption clinical sepsis
  • Need for mechanical ventilation
  • Body temperature above 38°C or below 36°C
  • Heart rate above 90 bpm
  • Systolic blood pressure of <90mm Hg despite adequate fluid replacement or a need for vasopressors less than 3 hours
  • Presence of at least one of the following criteria:
  • Ratio of arterial oxygen tension over inspired fraction of oxygen of less than 300 mm Hg
  • Urinary output below 0.5 mL per kg of bodyweight per h or below 30 mL/h (for at least 1 h)
  • Arterial lactate concentration above 2 mmol/L
  • Consent signed

Exclusion criteria

  • Age below 18 years
  • Pregnancy
  • Underlying disease with a poor prognosis, a life expectancy of less than 24 hours
  • Depression or melancholy
  • Neuropsychiatric diseases: Seizure, manic psychosis, Migraine, or Drug addiction
  • Neuroendocrine tumors
  • Obstructive cardiomyopathy or acute myocardial ischaemia
  • Pulmonary embolism
  • Advanced stage cancer, malignant haemopathy, or AIDS with a decision to withhold or withdraw aggressive therapies
  • Inclusion in another clinical trial
  • Patient who receive before inclusion one of the following treatment known to modify serotonin level: almotriptan, amitriptyline, amoxapine, citalopram, clomipramine, clozapine, desipramine, dihydroergotamine, dolasetron, dosulepin, doxepin, eletriptan, ergotamine, flunarizine, fluoxetine, fluvoxamine, granisetron, imipramine, indoramin, interferon Alfa, interferon alfacon-1, interferon beta, iproniazid, maprotiline, methysergide, mianserin, Milnacipran, mirtazapine, moclobemide, naratriptan, olanzapine, ondansetron, oxetorone, paroxetine, pizotifen, risperidone, sertraline, sumatriptan, tianeptine, trimipramine, tropisetron, venlafaxine,viloxazine, zolmitriptan.
  • No consent

Treatment and study plan

Primary outcomes

  1. Kinetics of 5-HT, 5-HIAA, kynurenine, tryptophan, HVA, VMA, DOPAC, Oestradiol, Cotinine and vasopressors

    Time frame: Day-1, Day-2, Day-3, Day-7 and Day-14

Secondary outcomes

  1. Mortality

    Time frame: 28-day

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Acronym: TSK

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
May 28, 2008
Registry last updated
Aug 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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